Software Device To Aid In The Prediction Or Diagnosis Of Sepsis
A software device to aid in the prediction or diagnosis of sepsis uses advanced algorithms to analyze patient-specific data and assist healthcare providers in predicting and/or diagnosing sepsis, potentially including alarms to alert care providers; it is intended for adjunctive use only and is not the sole basis for assessing sepsis status or monitoring treatment response. It is classified as FDA Class II (510(k) required) under regulation 880.6316 in the General Hospital specialty, with product code SAK. The device is not an implant and does not support life-sustaining functions.
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Basic Information
- Product Code
- SAK
- Device Class
- FDA class 2
- Regulation Number
- 880.6316
- Medical Specialty
- General Hospital
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
A software device to aid in the prediction or diagnosis of sepsis uses advanced algorithms to analyze patient specific data to aid health care providers in the prediction and/or diagnosis of sepsis. The device is intended for adjunctive use and is not intended to be used as the sole determining factor in assessing a patient's sepsis status. The device may contain alarms that alert the care provider of the patient's status. The device is not intended to monitor response to treatment in patients being treated for sepsis.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.